Ulcerative Colitis
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
Detailed description
This study consists of a screening period followed by a placebo-controlled Part 1 phase and then a placebo-controlled Part 2 phase. An open label Part 3 phase is open to subjects who: complete the Part 2, are considered non-responders following the Part 1, or have disease worsening during Part 2.
Interventions
DRUGSHR0302
Oral tablets taken once daily (QD)
DRUGPlacebo
Oral tablets taken once daily (QD)
Sponsors
Reistone Biopharma Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Part 1 1. Male or female subjects must be at least at ≥18 and ≤75 years of age 2. Subject has at least a three-month history of Ulcerative Colitis diagnosis at baseline. 3. Subject has active Ulcerative Colitis with a 9-point modified Mayo score of ≥ 5 at baseline, with an endoscopic subscore of ≥ 2 4. Subject is deemed by the physician as having inadequate response, loss of response or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or was previously exposed to anti-TNF therapy (e.g., infliximab, adalimumab) or other biological treatment (e.g., vedolizumab) having Discontinued the treatment for: * Infliximab: a minimum of 8 weeks prior to baseline. * Adalimumab: a minimum of 10 weeks prior to baseline. * Ustekinumab: a minimum of 14 weeks prior to baseline. * Vedolizumab: a minimum of 17 weeks prior to baseline. Inclusion Criteria for Part 2 1. Subject has completed Part 1 and achieved clinical response at week 8 Inclusion Criteria for Part 3 1\. Subject has completed the 8-week Part 1 and was classified as not meeting clinical response criteria. OR Subject has discontinued treatment early in the Maintenance phase due to disease worsening OR Subject has completed the Maintenance phase. Study
Exclusion criteria
for Part 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission at week 8 (Part 1) | 8 weeks | The percentage of subjects in clinical remission at week 8. |
| Clinical remission at week 52 (Part 2) | 52 weeks | The percentage of subjects in clinical remission at week 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in partial Mayo score at week 2, 4, and 8 (Part 1) | 8 weeks | Change from baseline in partial Mayo score at week 2, 4, and 8. |
| Change in total Mayo score and 9-point modified Mayo score at week 8 (Part 1) | 8 weeks | Change in total Mayo score and 9-point modified Mayo score at week 8. |
| Subjects with endoscopic remission (Part 2) | 52 weeks | The percentage of subjects with endoscopic remission at week 52. |
| Subjects with clinical response at week 52 (Part 2) | 52 weeks | The percentage of subjects with clinical response at week 52. |
| Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52 (Part 2) | 52 weeks | Change from baseline in partial Mayo score at week 12, 16, 24, 32, 40, and 52. |
| Endoscopic remission at week 8 (Part 1) | 8 weeks | The percentage of subjects with endoscopic remission at week 8. |
| Subjects in corticosteroid-free remission at week 52 (Part 2) | 52 weeks | Percentage of subjects in corticosteroid-free remission at week 52. |
| Subjects who maintain clinical remission at week 52 (Part 2) | 52 weeks | Percentage of subjects who maintain clinical remission at week 52 |
| Subjects in clinical remission per partial Mayo score at week E26 (Part 3) | 26 weeks (extension) | The percentage of subjects in clinical remission per partial Mayo score at week E26. |
| Subjects in corticosteroid-free remission per Partial Mayo score at week E26 (Part 3) | 26 weeks (extension) | The percentage of subjects in corticosteroid-free remission per Partial Mayo score at week E26. |
| Change from baseline in Partial Mayo score at week E2, E12, and E26 (Part 3) | 26 weeks (extension) | Change from baseline in Partial Mayo score at week E2, E12, and E26. |
| Change in total Mayo score and 9-point modified Mayo score at week 52 (Part 2) | 52 weeks | Change in total Mayo score and 9-point modified Mayo score at week 52. |
| Clinical response at week 8 (Part 1) | 8 weeks | The percentage of subjects with clinical response at week 8. |
Countries
China, Georgia, Poland, Ukraine, United States
Contacts
Primary ContactMinna Sun
Backup ContactLingyu Guo
Outcome results
None listed